MAUDE Adverse Event Report: CENTURION; DBD-TRIPLE LUMEN CVC INSERTION BUNDLE

Catalog Number	ECVC5020A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the wire "uncoiled inside the patient" during central line insertion but, it was "retrieved without injury".
Additional Manufacturer Narrative
According to the customer, the wire "uncoiled inside the patient" during central line insertion but, it was "retrieved without injury".The customer did not report any serious injury, medical intervention, or follow-up care related to the reported incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-TRIPLE LUMEN CVC INSERTION BUNDLE
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19737721
• Report Number: 3004519921-2024-00033
• Device Sequence Number: 3653977
• Product Code: LRO
• UDI-Device Identifier: 00653160364972
• UDI-Public: 00653160364972
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ECVC5020A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2024
• Initial Report FDA Received Date: 07/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown